The Effect of PXR Activation on Blood Pressure Regulation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Diastolic ambulatory blood pressure
研究概览
简要总结
We are investigating the effects of pregnane X receptor (PXR) activation on the regulation of blood pressure in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR activator) and placebo will be given for a week to volunteers and blood pressure is measured 24 hours using an ambulatory blood pressure monitor. Blood pressure regulating hormones will be measured in blood. Our hypothesis is that PXR is involved in the regulation of blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •BMI 19-30 kg/m2
- •Age 18-40 years
- •Systolic blood pressure 95 - 140 mmHg
排除标准
- •Any continuous medication
- •Any significant medical condition as judged by the study physician
- •Diastolic blood pressure over 90 mmHg
- •Sensitivity to rifampicin
- •Pregnancy and lactation
- •Difficult venipuncture
- •Abuse of alcohol or medications, or drug use.
- •Participation in other trial with medications in previous 30 days
研究组 & 干预措施
Rifampicin
Rifampicin 600 mg daily
干预措施: Rifampicin (Drug)
Placebo
Placebo daily
干预措施: Placebo (Drug)
结局指标
主要结局
Diastolic ambulatory blood pressure
时间窗: On day 8 of each arm
Diastolic blood pressure measured with ambulatory blood pressure monitor
Systolic ambulatory blood pressure
时间窗: On day 8 of each arm
Systolic blood pressure measured with ambulatory blood pressure monitor.
次要结局
- Systolic and diastolic blood pressure(On day 9 of each arm)
- Pulse (ambulatory)(On day 8 of each arm)
- Plasma renin activity(On day 9 of each arm)
- Serum aldosterone(On day 9 of each arm)